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| Name | Class |
|---|---|
| Centre of Postgraduate Medical Education | OTHER |
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This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.
Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC). Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. To improve detection chromoendoscopy is recommended. In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol). The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI endoscopy | Active Comparator |
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| lugol chromoendoscopy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI endoscopy | Procedure | GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value | The results of two methods are compare regarding positive predictive value. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the esophagoscopy ( NBI versus Lugol staining) | 2 years | |
| Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaroslaw Regula, PhD | Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland | Study Director |
| Anna Chaber-Ciopinska, MD | Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology | Warsaw | 02-781 | Poland |
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| Lugol chromoendoscopy | Procedure | GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions >= 5 mm diameter Pathologic examination of all biopsy tissue specimens |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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